Building Research for Intervention Development in Gliosis and Eating Habits

NCT06870578 | Recruiting DMC

• 2 other identifiers: STUDY000202812K24HL144917
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this study is to 1) use magnetic resonance imaging (MRI) to evaluate the effect of nutritious foods on inflammation in the human hypothalamus of children and 2) assess the feasibility and acceptability of nutritious food feeding intervention strategies in children with overweight or obesity.

Conditions

Gliosis; Child Obesity; Eating

Outcome Measures

Primary Outcomes (1)

• T2 relaxation time by brain MRI

  7 days of diet intervention

Study Arms (3)

Focus Group and Child Taste Test (Study 1)

NO INTERVENTION

No intervention is administered. Adult caregivers will participate in a focus group to assess feasibility of a controlled feeding study in children and children will complete a taste-test of a controlled feeding study menu.

Study-provided food (Study 2)

EXPERIMENTAL

Participants will be provided all meals for a 7-day period. For the other 7-days of their enrollment, they will be asked to consume their usual diet.

Other: Diet modification

Focus Group (Study 3)

NO INTERVENTION

No intervention is administered. Adult caregivers of children will participate in a focus group to learn from families about participating in research involving feeding studies in children.

Interventions

Diet modification OTHER

In Study 2 only, children will be provided all meals for a 7-day period. Meals will consist of nutritious foods, calories provided will exceed the child's estimated daily caloric need, and children will be asked to consume meals ad libitum.

Study-provided food (Study 2)

Eligibility Criteria

• Age: 9 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Study1: Adult caregiver and Child age 9-11y. Willing to come to in-person focus group
• Study 2: Age 9-11y, BMI ≥85th and ≤95th percentile for age and sex
• Study 3:Adult caregiver with child who qualify for free or reduced-cost lunch in WA State. Child age 9-11y and with overweight.

You may not qualify if:

• Significant health conditions including type 2 diabetes
• History of major weight loss or eating disorder
• Current use of medications known to alter appetite or body weight (e.g., stimulants for ADHD)
• Documented cognitive disorder
• Severe food allergies, vegetarian, or vegan (Study 1 only)
• Unable to make the session date
• Significant health conditions including type 2 diabetes
• History of major weight loss or eating disorder
• Current use of medications known to alter appetite or body weight (e.g., stimulants for ADHD)
• Documented cognitive disorder
• MRI contraindication (e.g., braces, claustrophobia)
• Weight \>330 pounds (MRI limit)
• Severe food allergies, vegetarian, or vegan
• Currently in formal weight loss program

Sponsors & Collaborators

• University of Washington: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

University of Washington

Seattle, Washington, 98109, United States

RECRUITING

MeSH Terms

Conditions

Gliosis; Pediatric Obesity

Interventions

Diet Therapy

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Nutrition Therapy; Therapeutics

Study Officials

• Ellen Schur, MD

  University of Washington

  PRINCIPAL INVESTIGATOR

Central Study Contacts

BRIDGE Study

CONTACT

206 616-6360; bridge-study@uw.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor: School of Medicine

Study Record Dates

• First Submitted: February 28, 2025
• First Posted: March 11, 2025
• Study Start: April 3, 2025
• Primary Completion (Estimated): June 1, 2029
• Study Completion (Estimated): June 1, 2029
• Last Updated: June 6, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)